PMID- 37776611 OWN - NLM STAT- MEDLINE DCOM- 20231127 LR - 20231127 IS - 1879-4076 (Electronic) IS - 1879-4068 (Linking) VI - 14 IP - 8 DP - 2023 Nov TI - Quality of life, effectiveness, and safety of aflibercept plus FOLFIRI in older patients with metastatic colorectal cancer: An analysis of the prospective QoLiTrap study. PG - 101638 LID - S1879-4068(23)00235-7 [pii] LID - 10.1016/j.jgo.2023.101638 [doi] AB - INTRODUCTION: Colorectal cancer (CRC) mainly affects older patients. The pivotal VELOUR phase III trial of aflibercept plus FOLFIRI in metastatic CRC (mCRC) included only 5.9% of patients aged >/=75 years. Herein, we report a preplanned analysis from QoLiTrap, a large prospective observational study evaluating the impact of age on quality of life (QoL), effectiveness, and safety of aflibercept plus FOLFIRI in daily clinical practice in Europe. MATERIALS AND METHODS: Enrolled patients had progressive mCRC, had failed a prior oxaliplatin-based regimen, and had received aflibercept (4 mg/kg) plus FOLFIRI every two weeks until disease progression, death, unacceptable toxicity, or physician/patient decision. Analyses were performed by age classes (<60, 60-64, 65-69, 70-74, and >/= 75 years). The primary endpoint was the percentage of patients whose global health status (GHS) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was maintained (i.e., no worsening from baseline by at least 5% over a 12-week treatment). Secondary endpoints included tumor objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Overall, 1277 patients (<60 years, n = 327; 60-64 years, n = 231; 65-69 years, n = 227; 70-74 years, n = 259; and >/= 75 years, n = 233) were treated, of whom 872 were evaluable for QoL. GHS was maintained in 36.5%, 41.6%, 38.9%, 41.8%, and 44.8% of patients aged <60, 60-64, 65-69, 70-74, and >/= 75 years, respectively. Age did not influence PFS (median 7.8 months), OS (median 14.4 months), or ORR (20.8%). Number of cycles, dose delays for any cause, and dose reductions for adverse events (AEs) were comparable between age classes. Grade >/= 3 AEs occurred in 47.7%, 51.9%, 51.5%, 55.2%, and 55.8% of patients aged <60, 60-64, 65-69, 70-74, and >/= 75 years, respectively. The main grade >/= 3 AEs were hypertension (11.2%) and diarrhea (9%) in patients aged >/=75 years. DISCUSSION: The results suggest that aflibercept plus FOLFIRI maintains QoL and retains its activity, including a high objective tumor response, regardless of age and treatment line. In fit older patients, the safety profile seems manageable, with no new safety signals. CI - Copyright (c) 2023 Elsevier Ltd. All rights reserved. FAU - Piringer, Gudrun AU - Piringer G AD - Department of Internal Medicine IV, Wels-Grieskirchen Hospital, Grieskirchner Str. 42, 4600 Wels, Austria; Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria. FAU - Thaler, Josef AU - Thaler J AD - Department of Internal Medicine IV, Wels-Grieskirchen Hospital, Grieskirchner Str. 42, 4600 Wels, Austria. FAU - Anchisi, Sandro AU - Anchisi S AD - Department of Oncology, Valais Romand Hospital Center, Valais Hospital, Av. Grand-Champsec 86, 1951 Sion, Switzerland. FAU - Geffriaud-Ricouard, Christine AU - Geffriaud-Ricouard C AD - Sanofi, Global Medical Oncology, 46 avenue de la Grande Armee, 75017 Paris, France. FAU - Gueldner, Max AU - Gueldner M AD - Sanofi-Aventis Deutschland GmbH, Luetzowstrasse 107, 10785 Berlin, Germany. FAU - Scholten, Felicitas AU - Scholten F AD - Department of Internal Medicine 3, Hematology, Oncology, Palliative Medicine and Pneumology, Frankfurt Hochst Clinic, Gotenstrasse 6-8, 65929 Frankfurt am Main, Germany. FAU - Derigs, Hans-Gunter AU - Derigs HG AD - Department of Internal Medicine 3, Hematology, Oncology, Palliative Medicine and Pneumology, Frankfurt Hochst Clinic, Gotenstrasse 6-8, 65929 Frankfurt am Main, Germany. FAU - Bohanes, Pierre AU - Bohanes P AD - Department of Oncology and Internal Medicine, Center for Chemotherapy, 1004 Lausanne, Switzerland. FAU - Grunberger, Birgit AU - Grunberger B AD - Department of Internal Medicine, Hematology and Oncology, Hospital Wiener Neustadt, Corvinusring 3-5, 2700 Wiener Neustadt, Austria. FAU - Schwarz, Leonora AU - Schwarz L AD - Department of Biometry, Alcedis, Winchesterstr 3, 35394 Giessen, Germany. FAU - von Moos, Roger AU - von Moos R AD - Department of Oncology, Cantonal Hospital Graubuenden, Loestrasse 170, 7000 Chur, Switzerland. FAU - Hofheinz, Ralf-Dieter AU - Hofheinz RD AD - Department of Oncology, University Hospital Mannheim, Theodor-Kutzer-Ufer 1, 68167 Mannheim, Germany. Electronic address: ralf.hofheinz@umm.de. LA - eng PT - Journal Article PT - Observational Study DEP - 20230928 PL - Netherlands TA - J Geriatr Oncol JT - Journal of geriatric oncology JID - 101534770 RN - 15C2VL427D (aflibercept) RN - U3P01618RT (Fluorouracil) RN - XT3Z54Z28A (Camptothecin) RN - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) RN - 0 (Recombinant Fusion Proteins) RN - Q573I9DVLP (Leucovorin) RN - 2S9ZZM9Q9V (Bevacizumab) SB - IM MH - Humans MH - Aged MH - *Colorectal Neoplasms/pathology MH - Quality of Life MH - Prospective Studies MH - Fluorouracil/adverse effects MH - Camptothecin/adverse effects MH - Receptors, Vascular Endothelial Growth Factor MH - *Colonic Neoplasms/drug therapy MH - *Rectal Neoplasms/drug therapy MH - Recombinant Fusion Proteins/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Leucovorin/adverse effects MH - Bevacizumab/therapeutic use OTO - NOTNLM OT - Aflibercept OT - Antiangiogenics OT - Bevacizumab OT - Colorectal cancer OT - EGFR inhibitors OT - Older adults OT - Quality of life OT - Safety OT - VEGF inhibitors COIS- Declaration of Competing Interest Christine Geffriaud-Ricouard and Max Gueldner are employees of Sanofi and may hold shares and/or stock options in the company. Leonora Schwarz is an employee of Alcedis GmbH, which was contracted for statistical analysis by Sanofi-Aventis. Sandro Anchisi received funding from Merck, Janssen-Cilag and Gilead Sciences Switzerland Sarl for participation in an advisory board; support from Celgene, Janssen-Cilag AG, Merck, MSD, and Roche for attending meetings; and honoraria for lectures from Sanofi-Aventis (Suisse). Pierre Bohanes received honoraria from Bayer and MSD. Birgit Grunberger received honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly, MSD, Pfizer, Pierre Fabre, Sanofi, and Servier; support for attending meetings from Merck, MSD, and Roche; and payment for participation in an advisory board from Bayer, Eli Lilly, MSD, Pfizer, and Roche. Ralf-Dieter Hofheinz received funding from Amgen, Deutsche Krebshilfe, Merck, and Sanofi; honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daichi, Eli Lilly, Medac, Merck, MSD, Pierre Fabre, Roche, Saladax, Servier and Sanofi-Aventis; and support for attending meetings from Amgen, AstraZeneca, Bayer, Bristol- Myers Squibb, Boehringer, Eli Lilly, Merck, MSD, Pierre Fabre, Roche, Sanofi, and Servier; as well as consulted for Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer, Daiichi, Eli Lilly, Merck, MDS, Pierre Fabre, Roche, Sanofi, and Servier. Felicitas Scholten received support for attending meetings from AbbVie, Glaxo-Smith Kline, Janssen, Novartis, and Servier, and for participation in an advisory board from Glaxo-Smith Kline. Roger von Moos received honoraria from Sanofi; consulted for Roche and Sanofi; and was paid for participation in advisory boards by Amgen, Merck Serono, MSD, and the Annals of Oncology. Hans-Gunter Derigs, Josef Thaler, and Gudrun Piringer declared no conflicts of interest. EDAT- 2023/10/01 04:44 MHDA- 2023/11/27 12:44 CRDT- 2023/09/30 18:03 PHST- 2023/04/25 00:00 [received] PHST- 2023/08/23 00:00 [revised] PHST- 2023/09/20 00:00 [accepted] PHST- 2023/11/27 12:44 [medline] PHST- 2023/10/01 04:44 [pubmed] PHST- 2023/09/30 18:03 [entrez] AID - S1879-4068(23)00235-7 [pii] AID - 10.1016/j.jgo.2023.101638 [doi] PST - ppublish SO - J Geriatr Oncol. 2023 Nov;14(8):101638. doi: 10.1016/j.jgo.2023.101638. Epub 2023 Sep 28.